Identity
- Trade Name
- FiberTech® FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, reusable FDA UDI
- Model / Reference
- LFR-200 FDA UDI
Identifiers
- Catalog Number
- 097139 FDA UDI
- Primary DI / UDI-DI
- 00816901020890 FDA UDI
- 510(k) Number
- K050738 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Urogenital surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urogenital surgical laser system beam guide, reusable
FiberTech® by WEINERT Fiber Optics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urogenital surgical laser system beam guide, reusable.
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Cleared under the same submission
K050738 also covers:
- CoolLipoTM — Leoni Fiber Optics, Inc.
- CoolLipoTM — Leoni Fiber Optics, Inc.
- CoolLipoTM — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech® — Leoni Fiber Optics, Inc.
- FiberTech — WEINERT Fiber Optics Inc.
- FiberTech — WEINERT Fiber Optics Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WEINERT Fiber Optics Inc.
Sources (1)
- FDA UDI ca1b5c2b-b98d-4eed-98bd-0ee85e517a62 34 fields · synced Jun 8, 2026